HeartLight® System

FDA registration

CARDIOFOCUS, INC.·1 product·🇺🇸 United States

HeartLight Deflectable Sheath

FDA registration

CARDIOFOCUS, INC.·2 products·🇺🇸 United States

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00868976000109·Laser Ablation Balloon Catheter

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00859373007433·HeartLight X3 Disposable Motor Catheter

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00868976000154·Laser Ablation Console

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00868976000161·Endoscopic Ablation Console (JP)

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00859373007440·HeartLight X3 Console, US

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00868976000123·Endoscope

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00868976000147·Deflectable Sheath

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00868976000178·Endoscopic Ablation Catheter

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00868976000116·Endoscopic Ablation Console (EU)

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00859373007495·HeartLight X3 Console, JP

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00868976000130·Balloon Fill Media

HeartLight

FDA UDI

CARDIOFOCUS, INC.·00859373007464·HeartLight X3 Console, EU

CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HeartLight Deflectable Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·HeartLight Catheter and HeartLight Console